Consent concerns in clinical trials of investigational therapies for COVID-19: Vulnerability versus voluntariness
Review Article
Arun Bhatt
Perspectives in Clinical Research, 6 October 2020
Abstract
Obtaining informed consent from vulnerable patients participating in clinical trials of investigational therapies for COVID-19 is a major ethical challenge. Ethical and operational considerations – voluntariness, waiver, timing, time, documentation, and responsibilities of the sponsor, the investigator, and the ethics committee – are discussed briefly.